WOODCOCK: MONOGRAPH UPDATES NECESSARY TO AVERT HEPARIN-LIKE OTC CRISIS

Abstract

Without monograph modernization efforts currently underway, outdated safety standards could lead to the demise of the over-the-counter drug system, FDA's top pharmaceutical official warned Thursday (Sept. 8) as the agency continues its work with the U.S. Pharmacopeia and industry to add components like identity and impurity tests to monographs.